[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639050":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":198,"collaborators":20,"id":202,"slug":203,"hasResults":204,"nctId":205,"briefTitle":206,"officialTitle":206,"acronym":20,"eligibilityCriteria":207,"healthyVolunteers":204,"sex":208,"minAge":209,"maxAge":210,"enrollmentInfo":211,"targetDuration":20,"studyType":214,"phases":215,"briefSummary":217,"conditions":218,"keywords":220,"overallStatus":222,"whyStopped":20,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":232},{"fullName":5,"class":6},"Jiangsu Cancer Institute & Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Fruquintinib Combined With Serplulimab and XELOX","EXPERIMENTAL","This study consists of two phases: combination and maintenance therapy. combination therapy administration： After screening and enrollment, patients will receive a first-line combination regimen of fruquintinib, serplulimab, and XELOX for 6-8 cycles.\n\nMaintenance therapy administration:\n\nAfter completion of the combination therapy, subjects with a response assessment of CR, PR, or SD, , will enter the maintenance phase:\n\nFruquintinib、Serplulimaband Capecitabine , until diseas progression, unacceptable toxicity, or voluntary withdrawal of informed consent NOTE: If lesions become resectable, surgical treatment should be performed.",[13],"Drug: Serplulimab+Fruquintinib+XELOX",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Serplulimab+Fruquintinib+XELOX","combination regimen of fruquintinib, serplulimab, and XELOX for 6-8 cycles. The dosing schedule is as follows: Fruquintinib: 3 mg\u002Fday, QD, PO, daily for 21 days of each 28-day cycle Serplulimab: 4.5 mg\u002Fkg, D1, intravenous infusion, Q3W XELOX ：Oxaliplatin: 130 mg\u002Fm², intravenous infusion over 0-2 hours, D1, Q3W Capecitabine: 1000 mg\u002Fm², PO, BID, D1-14, Q3W\n\nMaintenance therapy administration:\n\nAfter completion of the combination therapy, subjects with a response assessment of CR, PR, or SD, , will enter the maintenance phase:\n\nFruquintinib、Serplulimaband Capecitabine , until diseas progression, unacceptable toxicity, or voluntary withdrawal of informed consent",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Liang'jun Zhu","CONTACT","13505199123","zhulj98@foxmail.com",[28,45,54,59,72,81,94,100,113,122,135,144,157,167,180,193],{"facility":29,"status":20,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Changzhou Tumor Hospital (Changzhou Fourth People's Hospital)","Changzhou","Jiangsu","213000","China","CN",{"type":36,"coordinates":37},"Point",[38,39],119.95401,31.77359,{"lat":39,"lon":38},[42],{"name":43,"role":24,"phone":44,"phoneExt":20,"email":20},"Yong Liu","13921033137",{"facility":46,"status":20,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":47,"geoPoint":49,"contacts":50},"Liyang People's Hospital",{"type":36,"coordinates":48},[38,39],{"lat":39,"lon":38},[51],{"name":52,"role":24,"phone":53,"phoneExt":20,"email":20},"Liqun Zhu","13626255262",{"facility":55,"status":20,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":56,"geoPoint":58,"contacts":20},"The First People's Hospital of Changzhou",{"type":36,"coordinates":57},[38,39],{"lat":39,"lon":38},{"facility":60,"status":20,"city":61,"state":31,"zip":62,"country":33,"countryCode":34,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Huaian First People's Hospital","Huai'an","223000",{"type":36,"coordinates":64},[65,66],119.01917,33.58861,{"lat":66,"lon":65},[69],{"name":70,"role":24,"phone":71,"phoneExt":20,"email":20},"Xiaomin Zhong","13912074971",{"facility":73,"status":20,"city":74,"state":31,"zip":75,"country":33,"countryCode":34,"cosmosGeoPoint":76,"geoPoint":80,"contacts":20},"The First People's Hospital of Lianyungang","Lianyungang","222000",{"type":36,"coordinates":77},[78,79],119.21556,34.59845,{"lat":79,"lon":78},{"facility":82,"status":20,"city":83,"state":31,"zip":84,"country":33,"countryCode":34,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"First Affiliated Hospital of Nanjing Medical Unviersity","Nanjing","210000",{"type":36,"coordinates":86},[87,88],118.77778,32.06167,{"lat":88,"lon":87},[91],{"name":92,"role":24,"phone":93,"phoneExt":20,"email":20},"Jing Sun","13914704178",{"facility":5,"status":20,"city":83,"state":31,"zip":84,"country":33,"countryCode":34,"cosmosGeoPoint":95,"geoPoint":97,"contacts":98},{"type":36,"coordinates":96},[87,88],{"lat":88,"lon":87},[99],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"facility":101,"status":20,"city":102,"state":31,"zip":103,"country":33,"countryCode":34,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Nantong University Cancer Hospital","Nantong","226000",{"type":36,"coordinates":105},[106,107],120.87472,32.03028,{"lat":107,"lon":106},[110],{"name":111,"role":24,"phone":112,"phoneExt":20,"email":20},"Lei Yang","158 5139 8092",{"facility":114,"status":20,"city":102,"state":31,"zip":103,"country":33,"countryCode":34,"cosmosGeoPoint":115,"geoPoint":117,"contacts":118},"The First People's Hospital of Nantong",{"type":36,"coordinates":116},[106,107],{"lat":107,"lon":106},[119],{"name":120,"role":24,"phone":121,"phoneExt":20,"email":20},"Liang zhang","137 0629 5558",{"facility":123,"status":20,"city":124,"state":31,"zip":125,"country":33,"countryCode":34,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Changshu No.2 People's Hospital","Suzhou","215000",{"type":36,"coordinates":127},[128,129],120.59538,31.30408,{"lat":129,"lon":128},[132],{"name":133,"role":24,"phone":134,"phoneExt":20,"email":20},"Yulan Gu","13812971602",{"facility":136,"status":20,"city":124,"state":31,"zip":125,"country":33,"countryCode":34,"cosmosGeoPoint":137,"geoPoint":139,"contacts":140},"Suzhou Municipal Hospital",{"type":36,"coordinates":138},[128,129],{"lat":129,"lon":128},[141],{"name":142,"role":24,"phone":143,"phoneExt":20,"email":20},"jianming Shi","138 1525 9001",{"facility":145,"status":20,"city":146,"state":31,"zip":147,"country":33,"countryCode":34,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"Wuxi Huishan District People's Hospital","Wuxi","214000",{"type":36,"coordinates":149},[150,151],120.28857,31.56887,{"lat":151,"lon":150},[154],{"name":155,"role":24,"phone":156,"phoneExt":20,"email":20},"Ning Ding","177 0617 8690",{"facility":158,"status":20,"city":146,"state":31,"zip":159,"country":33,"countryCode":34,"cosmosGeoPoint":160,"geoPoint":162,"contacts":163},"Jiangyin People's Hospital","214400",{"type":36,"coordinates":161},[150,151],{"lat":151,"lon":150},[164],{"name":165,"role":24,"phone":166,"phoneExt":20,"email":20},"Qiong Wang","136 0616 8002",{"facility":168,"status":20,"city":169,"state":31,"zip":170,"country":33,"countryCode":34,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"Xuzhou First People's Hospital","Xuzhou","221000",{"type":36,"coordinates":172},[173,174],117.28386,34.20442,{"lat":174,"lon":173},[177],{"name":178,"role":24,"phone":179,"phoneExt":20,"email":20},"Taifeng Liu","13685183529",{"facility":181,"status":20,"city":182,"state":31,"zip":183,"country":33,"countryCode":34,"cosmosGeoPoint":184,"geoPoint":188,"contacts":189},"Yangzhou University Affiliated Jiangdu People's Hospital","Yangzhou","225000",{"type":36,"coordinates":185},[186,187],119.43583,32.39722,{"lat":187,"lon":186},[190],{"name":191,"role":24,"phone":192,"phoneExt":20,"email":20},"Min Liao","15952578622",{"facility":194,"status":20,"city":182,"state":31,"zip":183,"country":33,"countryCode":34,"cosmosGeoPoint":195,"geoPoint":197,"contacts":20},"Yizheng People's Hospital",{"type":36,"coordinates":196},[186,187],{"lat":187,"lon":186},{"type":199,"investigatorFullName":200,"investigatorTitle":201,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Liangjun Zhu M.M.","Chief Physician, Department of Medical Oncology","100639050","phase-2-a-single-arm-multicenter-clinical-study-of-fruquintinib-combined-with-serplulimab-and-chemotherapy-as-first-line-treatment-for-patients-with-rasbraf-mutated-advanced-colorectal-cance-100639050",false,"NCT07622550","A Single-arm, Multicenter Clinical Study of Fruquintinib Combined With Serplulimab and Chemotherapy as First-line Treatment for Patients With RAS\u002FBRAF-mutated Advanced Colorectal Cance","Inclusion Criteria:\n\n* 18 to 75 years (inclusive), male or female.\n* Diagnosis of advanced unresectable or metastatic colorectal cancer.\n* Confirmed RAS\u002FBRAF mutation by testing.\n* No prior systemic therapy for unresectable or metastatic colorectal cancer. (Prior adjuvant or neoadjuvant chemotherapy with one regimen is allowed if recurrence occurred ≥6 months after completion of chemotherapy.)\n* ECOG 0 - 1.\n* Adequate major organ and bone marrow function (without any blood component or cell growth factor support within 14 days before enrollment):\n\n  1. Hematology: absolute neutrophil count ≥1.5 × 10⁹\u002FL, platelet count ≥100 × 10⁹\u002FL, hemoglobin ≥90 g\u002FL.\n  2. International normalized ratio (INR) ≤1.5 × upper limit of normal (ULN), and activated partial thromboplastin time (APTT) ≤1.5 × ULN.\n  3. Liver function: total bilirubin ≤1.5 × ULN; ALT\u002FAST ≤2.5 × ULN (≤5 × ULN in patients with liver metastases).\n  4. Renal function: serum creatinine ≤1.5 × ULN, and creatinine clearance (CCr) ≥50 mL\u002Fmin.\n* Female patients of childbearing potential must have a negative serum pregnancy test within 14 days before treatment. Fertile patients (male and female) must agree to use reliable contraceptive methods (hormonal, barrier, or abstinence) with their partners during the study and for at least 6 months after the last dose\n\nExclusion Criteria:\n\n* \\- History of hypersensitivity to any anti-angiogenic targeted agent, any component of monoclonal antibodies, capecitabine, oxaliplatin, or other platinum-based drugs.\n* Untreated central nervous system (CNS) metastases.\n* Major surgery or severe trauma within 4 weeks prior to first study drug administration.\n* Current use of immunosuppressive agents, or systemic or absorbable local hormone therapy for immunosuppressive purposes (dose \\>10 mg\u002Fday prednisone or equivalent), and continued use within 2 weeks before enrollment.\n* Presence of any active autoimmune disease or history of autoimmune disease.\n* History of other malignancies within the past 5 years, except for radically resected basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.\n* Known inherited or acquired bleeding\u002Fthrombotic tendency (e.g., hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.) or currently receiving thrombolytic or anticoagulant therapy.\n* Currently active bleeding or significant bleeding tendency within 3 months (i.e., patients at high risk of bleeding).","ALL","18 Years","75 Years",{"count":212,"type":213},80,"ESTIMATED","INTERVENTIONAL",[216],"PHASE2","This study is a prospective, single-arm, multicenter exploratory clinical study aimed at evaluating the efficacy and safety of Fruquintinib combined With Serplulimab and chemotherapy as first-line treatment for RAS\u002FBRAF-mutated unresectable advanced colorectal cancer. The study plans to enroll 80 patients with RAS\u002FBRAF-mutated unresectable advanced metastatic colorectal cancer. After evaluation and confirmation of meeting enrollment criteria, patients will receive treatment with Fruquintinib combined With Serplulimab and chemotherapy . The primary endpoint of the study is PFS, and secondary endpoints include ORR, DCR, OS, and safety.",[219],"Metastatic Colorectal Cancer (CRC)",[221],"RAS\u002FBRAF-mutated","NOT_YET_RECRUITING","2026-05-28",{"date":225,"type":226},"2026-06-03","ACTUAL",{"date":228,"type":213},"2026-06-15",{"date":230,"type":213},"2028-08-15",{"name":5,"class":6},16]